Source: Alar Pharmaceuticals
Single-ascending-dose (SAD) study successfully demonstrated the safety, tolerability, and sustained release profile at least 3 months resulting from ALA-1000 injection in patients with opioid dependence.
Alar Pharmaceuticals Inc. (Alar, TWSE:6785), a clinical-stage biopharmaceutical company focused on developing long-acting injectables (LAIs) for central nervous system disorders, announces the completion and positive results of ALA-1000 SAD study (A1-19-P01). The results represent the first demonstration of safety, tolerability, and pharmacokinetic (PK) durability for ALA-1000, a subcutaneous LAI formulation releasing buprenorphine, in patients with opioid use disorder (OUD) administered subcutaneously.
Based on the data of safety assessments, subcutaneous injections of ALA-1000 were well-tolerated in all dose-escalation cohorts. All the drug-related adverse events (AEs) were mild or moderate in severity and were consistent with expected opioid withdrawal and known pharmacology effects of buprenorphine. No significant or unexpected safety findings were identified in this first-in-human study. The injection site reactions were scored as none mostly or mild rarely and resolved within 1 hour mainly. No subjects discontinued the study due to injection site reactions. ALA-1000 achieved anticipated PK profile in human, i.e., consistent buprenorphine-release with therapeutically effective plasma levels for at least 3 months but low fluctuation and without dose dumping, significant initial burst.
The secondary endpoints regarding efficacy demonstrated that patients who received single ALA-1000 injection at target dose remained relatively mild withdrawal signs and symptoms (mean score < 5 on Clinical Opiate Withdrawal Scale [COWS]) and opioid craving (≤ 14 mm on the Opioid Craving Visual Analog Scale [VAS]), and displayed ≥ 80% negative urine opioids toxicology results during the outpatient phase (up to Day 175).
"This SAD study demonstrates that ALA-1000 brings sustained releasing profile in various dose strengths, therefore, ALA-1000 can not only provide a new solution for the opioid crisis but can contribute to chronic pain management." said Yung-Shun Wen, CEO of Alar Pharmaceuticals.
"A breakthrough in developing this new medication for OUD has been made," said Charles Lin, Founder and Chairman of Alar Pharmaceuticals, "We firmly believe that these successful clinical outcomes of ALA-1000 support us to accelerate the later clinical development and launching to provide a better choice for patients and physicians. We look forward to working with potential collaboration partners to bring this novel treatment to the patients suffering from OUD."
Alar has completed a successful end-of-phase 2 meeting with US FDA for ALA-1000. The phase III pivotal trial to support NDA application is planned to initiate this year.